Welcome to the conference hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2023, and to provide a General Business Update. This call is being recorded. My name is Mark and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Commercial Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon, and welcome to the financial results and business update call for the quarter ended June 30, 2023 for Daré Bioscience. For those of you joining us via webcast, you should be able to access presentation slides from within the webcast module. We’ve included the slides to provide some additional context on our portfolio that you may find helpful while you listen to the call. The slide deck is also available in the Investor Relations section of our website under Presentations, Events and Webcast and will remain on the site for two weeks. Today we will review our second quarter results, and discuss developments and expectations for XACIATO commercialization and for two of our late-stage investigational products, our hormone-free monthly, intravaginal contraceptive candidate Ovaprene and Sildenafil Cream 3.6% which is being developed as a treatment for arousal disorder in women. Before we begin, I would like to remind you that today’s discussion will include forward-looking statements within the meaning of federal securities laws which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company’s SEC filings, including our Form 10-Q for the quarter ended June 30, 2023 which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 10, 2023. Daré undertakes no obligation to update any forward-looking statements…

Thank you, Sabrina. As a reminder, XACIATO clindamycin phosphate vaginal gel is lincosamide antibacterial for single dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients, 12 years of age and older in the United States. Organon, our global commercial collaborator believes there's roughly a 90% overlap of healthcare providers who prescribe their contraceptive product NEXPLANON and have the potential to be prescribers of XACIATO, based on provider treatment patterns. Because of these strong relationships, the Organon sales team has with these healthcare providers, we expect Organon to be well-positioned to detail XACIATO and drive product prescriptions and pullthrough on day one of launch. We believe that XACIATO should be well-positioned for commercial success, given the knowledge and experience of Organon’s Nexplanon sales team, coupled with their planned marketing and payer outreach initiatives as we have outlined on previous calls and we plan to provide further updates once the product is on the market. Organon and Daré are working towards a US launch as soon as feasible. Looking ahead to our later-stage programs, in parallel with the Ovaprene Phase 3 study activities, our team has been busy working with our collaborator Bayer on key commercial initiatives to ensure a seamless transition from clinical development to commercial introduction. We have organized a cross-functional team to align and activate on key aspects of the brand, including packaging, messaging and key opinion leader targeting. These activities will help set the foundation for additional downstream, post-approval sales and marketing activities. And finally, we are truly excited about the progress on the Sildenafil Cream program. As we continue to analyze the data we are planning to implement a robust medical communication strategy to make sure we are educating all of the key stakeholders in women's health and sexual health on key aspects of the condition, including pathophysiology and quality of life issues and plan to work with our colleagues on the medical side to ensure broad dissemination of this information. We will have more information on these initiatives moving forward, but we remain very excited about the opportunity to bring forward a first in category solution like Sildenafil Cream that has the potential to improve the lives of millions of women dealing with sexual disorder and bring a much-needed new option for providers that currently have nothing to prescribe them. With that. I will turn the call over to Lisa.

Thank you, John. And thanks for all of you for joining today. I would now like to summarize Daré’s financial results for the quarter ended June 30th 2023, which I will refer to as the current quarter or the second quarter. As, you know, Daré’s business model is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet means that we've identified in women's health and then to monetize the value of the portfolio's clinical and regulatory advantage over the near and long-term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D expenses. During the second quarter, our general and administrative or G&A expenses were approximately $2.9 million. Our R&D expenses, which vary from period-to-period based on our clinical, preclinical, manufacturing, regulatory and other activities across our entire portfolio were approximately $6 million and primarily reflected the cost associated with the Sildenafil Cream Phase,2b RESPOND clinical trial that Sabrina just summarized and manufacturing and regulatory affairs activities related to Ovaprene’s planned Phase 3 study. Our comprehensive loss for the current quarter was approximately $8.7 million. We ended the current quarter with approximately $13.3 million in cash and cash equivalents. And as of August 9th 2023, we had approximately 87.8 million shares of common stock outstanding. Under our license agreement with Organon for XACIATO, we received $1 million in July and we are entitled to receive $1.8 million following the first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million, as well as tiered, double-digit royalties based on XACIATO’s net sales. We are continuing to explore a variety of options to fund our operations and advance our candidates, monetize the value of our assets and build shareholder value. These alternatives include, but are not limited to non-dilutive grants like the one we recently received from the NIH for a preclinical candidate, equity sales, license agreement, structured financings, and strategic collaborations or alliances. As we said previously, we will endeavor to be creative, collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We encourage all investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, risk factors in the Form 10-Q for the quarter ended June 30th 2023, which we filed today, and in our Annual Report on form 10-K for the year ended December 31st 2022, which was filed on March 30th 2023. I would now like to turn the call over to the operator.

Thank you for attending the conference call. [Operator Instructions] Our first question comes from the line of Catherine Novack with Jones Research. Catherine, the line is now open.

Hi. Good afternoon. Thanks for taking my question. I guess just, a couple questions on Ovaprene. Can you remind us what’s still gating to the initiation of the study? And what are some key inclusion exclusion criteria that you are anticipating that might affect the screen rate and enrollment rate of the study?

Yeah, great questions. And thanks for your questions as always. In terms of what’s gating the start of the study, we're really gearing up to be ready to go. So, as I've mentioned in my comments today, we're working with the NIH, the NICHD on the conduct of the study and they actually held an investigator meeting with the investigators who identified for the Ovaprene study actually last December. So these investigators are been excited in prime for a while. You may recall, there were some comments from the FDA when we got our IDE approval to move forward with the study with some recommendations on some tweaks around considerations around the protocol that they encouraged us to make to ensure that it would meet all their expectations. And so we have done that. And then we've been getting the sites kind of reoriented to the protocol and ready to go. And so, we're really preparing to initiate enrollment now in the fourth quarter. And then, obviously, we've been manufacturing with our partner to prepare for that. So, we're super excited to get started obviously, and all the pieces are coming together and are on track right now for that. In terms of and all the sites as I mentioned, there's a clinical trial, their networks - the Contraceptive Clinical Trial Network sites that are participating in this study. So it's about 20 sites right now that are participating in the study. And so they are, they're almost set up. In terms of the key in kind of inclusion exclusion criteria, it's pretty standard for a contraceptive study. So patients have to be a certain age. They have to be in a committed partnership. They have to have a commitment to have certain number of sexual events every month. So…

No. That was very helpful. Just curious, if you can talk about the expected geographic spread of the 20 sites and I'm curious what you're seeing in terms of enrollment dynamic based on, I guess, you would say the political environment.

Yeah, I go to Seattle.

Right. And what's the level of interest across different areas of the U.S.?

Yeah. Fantastic question. So the sites are spread across the country. So, pretty, good diversity across the country in terms of where the sites are. And that also means there's some diversity in terms of kind of what the reproductive right landscape is in a particular state, where that site is. What we've seen across the board and these are investigators that have all participated in lots of contraceptive studies and are very experienced in that regard, their view is that obviously, it's a factor, right? It's something that people are considering and certainly people that are signing up for a contraceptive study, by definition they have to be open to the fact that they may get pregnant right? It's an investigational product. And so they have to be aware that that is a factor. And where they reside that may be more meaningful to them than maybe in a different state in terms of what their propensity and comfort with that is. But all of the sites feel that, none of them have really projected that it would change how they anticipate enrollment progressing. Because their view is that it's always a consideration anyhow and then, in general people who tend to participate in contraceptive studies generally have a good acceptance of the fact that they may get pregnant and are prepared for that outcome. But it's definitely something that has been [Aidio Gap] Sort of the cost providing the Ovaprene supplies for the study. And then, the way the creative works is Daré puts funds into basically to the NIH basically into an account for use in the study. So we have contributed our $5 million today to that account. There's another $500,000 that we would anticipate right now providing this year to support the study, as well. And those funds should be sufficient. However, clinical trial costs can vary, right, as you've said as progress things happen, right? Or if we add additional sites so there are a number of factors that could change the cost of the study. And so if that happens, then we and the NIH would come together and decide what our contribution would be, what their contribution would be if that were to happen and adjust accordingly. But right now, like we've put our monies there and those are the funds along with support from the NIH to conduct the study.

Okay, that's very helpful. Thanks for taking my questions. Have a great afternoon.

Yeah. Thank you.

[Operator Instructions] Your next question comes from the line of Michael Elsa - Michael. I'm sorry, but I think we lost Michael. Okay. So there are no further questions at this time, I would like to turn the call back over to our presenters.

Alright. Well, thank you for taking the time this afternoon to hear about our recent updates and ongoing commitment to drive value for Daré stakeholders, women, health care providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and well-being expand treatment options where none exists, enhance outcomes where current standard-of-care has meaningful shortcomings and improve ease of use for women, where a more compelling form factor can drive adoption, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. We definitely look forward to keeping you updated on our progress towards the milestones we discussed today. Specifically, our XACIATO product launch and first commercial sale by Organon. As John mentioned, we are working together to achieve a 2023 launch as soon as feasible. Patient enrollment in the Phase 3 clinical study of Ovaprene, our investigational potential first in category, hormone-free monthly intravaginal contraceptive, whose US commercial rights are under the license agreement with Bayer. And as we just discussed, we expect that single pivotal study to support Ovaprene’s pre-market, approval application and enrollment is targeted to commence this fourth quarter of this year. We're also looking forward to our end of Phase 2 meeting with the FDA and finalization of a Phase 3 protocol for the next Sildenafil Cream study. In addition, we look forward to announcing data later this year from our Phase 1 study evaluating a vaginal gel formulation of Aceclofenac being developed as a treatment for menstrual pain and cramps, as well as ongoing activities related to IND and Phase 3 and Phase 2, preparations for our two menopause programs, hormone therapy for the vasomotor symptoms of menopause and hormone free vulvovaginal atrophy treatment respectively. So with that, I thank you again for your time today and for your support. Thank you.

This concludes today's conference call. You may now disconnect.